MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC260FW manufactured by Olympus Medical Systems Corp..
[103153084]
The subject device has not been returned to omsc but was returned to (b)(4). As a result of this device confirmation, (b)(4) confirmed the reported event. Also it was confirmed that the leakage from the instrument channel and the bending section rubber of this device, furthermore there was a pinhole in the bending section rubber. Also omsc reviewed the manufacturing history of this device and confirmed no irregularity. The user facility reported that the black spots were not there at the time of inspection before use. On the other hand, the physician reported that this reported event may have occurred by stinging the instrument channel of this device with a needle by mistake. From the above, it is considered that the image guide fiber of this device was damaged due to stinging a needle by mistake and the reported event occurred.
Patient Sequence No: 1, Text Type: N, H10
[103153085]
Olympus medical systems corp. (omsc) was informed that the user facility noticed multiple black spots in the image of the subject device, during the unspecified procedure. After that, the user facility safely withdrew this device from the patient. At a later date, the user facility carried out the intended procedure on the patient and completed it. There was no patient injury associated with this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-00445 |
| MDR Report Key | 7340594 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-02-14 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2012-10-16 |
| Date Added to Maude | 2018-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Generic Name | ULTRASONIC BRONCHOFIBERVIDEOSCOPE |
| Product Code | PSV |
| Date Received | 2018-03-15 |
| Model Number | BF-UC260FW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-15 |